Patient Encounters
What is a requirement for a valid informed consent process regarding physician and patient signatures?
Consents are signed on the same day by the physician and the patient.
What report is required when an eligibility violation is discovered after a patient has been enrolled on a clinical trial?
Submission of a Reportable New Information (RNI)
When should the treating physician sign the Inclusion/Exclusion form for a patient starting study treatment?
The Inclusion/Exclusion form should be signed by the treating physician before treatment begins, preferably on the same day as the C1D1 clearance.
Who should the patient call to report symptoms?
The CCTT Clinic Triage line
Con meds should be reviewed at what timepoint?
Following completion of the VTPS, whose signature is obtained next on the informed consent form?
The MD and the witness